Abstract | AIMS/HYPOTHESIS: METHODS: A 12-week, multicentre, randomised, double-blind, placebo-controlled, dose-finding study compared the efficacy and safety of oral tesaglitazar (0.1, 0.25, 0.5 and 1.0 mg/day) and placebo in 390 non-diabetic patients with hypertriglyceridaemia (plasma triglyceride concentration >1.7 mmol/l) and abdominal obesity (waist-to-hip ratio >0.90 for men and >0.85 for women). RESULTS: A 1.0-mg dose of tesaglitazar reduced fasting triglycerides (the primary endpoint) by 37% (95% CI: -43% to -30%; p<0.0001), non- HDL-cholesterol by 15% (95% CI: -20% to -10%; p<0.0001) and NEFA by 40% (95% CI: -51% to -27%; p<0.0001), and increased HDL-cholesterol by 16% (95% CI: 8 to -24%; p<0.0001). At the end of treatment there was a dose-dependent increase in patients with pattern A LDL particle diameter (40% at baseline vs 87% at 12 weeks for tesaglitazar 1.0 mg). Tesaglitazar produced significant reductions in fasting insulin concentration (-35%; p<0.0001) and plasma glucose concentration (-0.47 mmol/l; p<0.0001). Respiratory infection and gastrointestinal symptoms were the most common adverse events and were similarly frequent in all groups. CONCLUSIONS/INTERPRETATION:
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Authors | B Fagerberg, S Edwards, T Halmos, J Lopatynski, H Schuster, S Stender, G Stoa-Birketvedt, S Tonstad, S Halldórsdóttir, I Gause-Nilsson |
Journal | Diabetologia
(Diabetologia)
Vol. 48
Issue 9
Pg. 1716-25
(Sep 2005)
ISSN: 0012-186X [Print] Germany |
PMID | 16001233
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Alkanesulfonates
- Blood Glucose
- Fatty Acids, Nonesterified
- Insulin
- Lipids
- PPAR alpha
- PPAR gamma
- Phenylpropionates
- Placebos
- Triglycerides
- tesaglitazar
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Topics |
- Alkanesulfonates
(adverse effects, therapeutic use)
- Blood Glucose
(drug effects, metabolism)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Fatty Acids, Nonesterified
(blood)
- Female
- Humans
- Insulin
(blood)
- Lipids
(blood)
- Male
- Middle Aged
- PPAR alpha
(antagonists & inhibitors)
- PPAR gamma
(antagonists & inhibitors)
- Phenylpropionates
(adverse effects, therapeutic use)
- Placebos
- Safety
- Triglycerides
(blood)
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